Wednesday, March 23, 2022

 

§ 3.2-4901. Exemptions from chapter - Virginia Law

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Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification U.S. Food and Drug Administration sent this bulletin at 03/21/2022 02:14 PM EDT

 Olympia Pharmacy has issued a voluntary nationwide recall of seven compounded products due to being out-of-specification. The voluntary recall is for 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level.

Risk Statement: Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.

Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.

Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients. FDA’s compounding program aims to protect patients from unsafe, ineffective and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.

 

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Thursday, March 17, 2022

Former Owner of New Jersey Marketing Company Admits Role in $6 Million Compounded Prescription Drug Scheme

Department of Justice
U.S. Attorney’s Office
District of New Jersey

FOR IMMEDIATE RELEASE
Thursday, March 17, 2022

Former Owner of New Jersey Marketing Company Admits Role in $6 Million Compounded Prescription Drug Scheme

NEWARK, N.J. – The former owner of a New Jersey marketing company admitted his role in a scheme to defraud public and private health benefits programs of over $6 million for the billing of medically unnecessary compounded prescriptions, U.S. Attorney Philip R. Sellinger announced today. 

Michael Drobish, 43, of Cedar Grove, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez on March 16, 2022, to an information charging him with conspiracy to commit health care fraud.

According to documents filed in this case and statements made in court:

Compounding is a practice in which a pharmacist or physician combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The Food and Drug Administration does not approve compounded drugs and thus does not verify the safety, potency, effectiveness, or manufacturing quality of compounded drugs. Generally, a physician may prescribe compounded drugs when an FDA-approved drug does not meet the health needs of a particular patient.

Between April 2014 and January 2017, Drobish conspired with others to submit fraudulent prescriptions for compounded medications to public and private insurance plans. The scheme centered on the discovery that certain insurance plans paid for prescription compounded medications – including scar creams, wound creams, and metabolic supplements/vitamins – at exorbitant reimbursement rates.

Drobish hired sales representatives through his marketing company to target individuals who had insurance plans that covered compounded medications. The sales representatives then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity, often by providing them with cash payments. The individuals were then directed to certain telemedicine companies, which the marketing company or its affiliates paid to issue the prescriptions. The prescribing physicians at the telemedicine companies would then write the prescriptions without performing any examination or after deliberately conducting cursory examinations that were insufficient to legitimately deem a compounded drug medically necessary. 

Once the prescriptions were written, they were filled by certain compounding pharmacies with which Drobish conspired. The compounding pharmacies would then receive reimbursement from the insurance plans, and would pay Drobish’s marketing company a percentage of the reimbursement amount. Drobish would retain a portion of the payment and provide a “commission” payment to the relevant sales representative.

The conspiracy to commit health care fraud charge carries a maximum penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense. As part of his plea agreement, Drobish must forfeit $532,650 in criminal proceeds and pay restitution of at least $6.1 million. Sentencing is scheduled for July 19, 2022.

U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr., and the U.S. Department of Defense Office of Inspector General, Defense Criminal Investigative Service, under the direction of Special Agent in Charge Patrick J. Hegarty, with the investigation leading to today’s guilty plea.

The government is represented by Assistant U.S. Attorney Adam Baker of the U.S. Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
22-100
Updated March 17, 2022

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Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

 

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Products are out of specification
Company Name:
Olympia Pharmacy
Brand Name:
Olympia Pharmaceuticals
Product Description:
Compounded Injectables

Company Announcement

Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.

Risk Statement: Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.

Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.

The compounded products being recalled are typically prescribed by medical professionals for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder. The affected lots include the following lot numbers and expiration dates listed below. The product can be identified by reading the lot number in the black strike zone of the label and was distributed to patients and health clinics.

DrugVial SizeLotBest Use Date
NAD500mg vialC410083/8/22
NAD500mg vialD240054/5/22
Sincalide5 mcg vialD240014/1/22
Trimix Formula F910 ml vialD41C194/19/22
Sermorelin Acetate 9 mg9 mg vialD440264/26/22
Sermorelin Acetate 9 mg9 mg vialF421046/4/22
Trimix T-105,5 ml vialE41F105/10/22
Trimix T-105,10 ml vialE41G105/10/22
Trimix SB-45 ml vialE41C185/18/22
Trimix SB-410 ml vialE41D185/18/22
Hydroxocobalamin 1mg/ml30 ml vialE470255/21/22

Olympia Pharmacy is notifying its customers by mail and is arranging for return and replacement of all recalled compounded products. Patients and health clinics that have any of the listed compounded products which are being recalled should stop using and return to Olympia Pharmacy.

Consumers with questions regarding this recall can contact Olympia Pharmacy by phone at 407-250-4000 or e-mail clientservices@olympiapharmacy.com Monday through Friday from 9 am to 6 pm Eastern Standard Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

"Kent Courtheyn, 38, of Kent, Ohio, owner and operator of two marketing companies involved in the sales and marketing of compounded medications – IntegriMed Solutions LLC (IntegriMed) and KA Compounding LLC (KA Compounding) – pleaded guilty by videoconference before U.S. District Judge Madeline Cox Arleo to an information charging him with conspiracy to defraud the United States by committing health care fraud and violating the anti-kickback statute."

 Department of Justice

U.S. Attorney’s Office
District of New Jersey

FOR IMMEDIATE RELEASE
Monday, March 14, 2022

Ohio Man Admits Role in Multimillion-Dollar Scheme to Defraud Health Care Benefit Programs

NEWARK, N.J. – An Ohio man pleaded guilty today to his role in a large-scale, multilevel marketing scheme to defraud private and federally funded health care benefit programs, U.S. Attorney Philip R. Sellinger announced.

Kent Courtheyn, 38, of Kent, Ohio, owner and operator of two marketing companies involved in the sales and marketing of compounded medications – IntegriMed Solutions LLC (IntegriMed) and KA Compounding LLC (KA Compounding) – pleaded guilty by videoconference before U.S. District Judge Madeline Cox Arleo to an information charging him with conspiracy to defraud the United States by committing health care fraud and violating the anti-kickback statute.

According to documents filed in this case and statements made in court:

TRICARE is a health care entitlement program of the U.S. Department of Defense (DoD) Military Health System that provides coverage for DoD beneficiaries worldwide, including active duty service members, National Guard and Reserve members, retirees, their families, and survivors. Compounded medications are specialty medications prepared by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a medical professional determines that an FDA-approved medication does not meet the health needs of a particular patient, such as when a patient is allergic to a dye or other ingredient or when a patient cannot consume a medication by traditional means.

From July 2014 through July 2016, Courtheyn, a former medical device sales representative, ran a large-scale scheme to defraud federally funded health care benefit programs, such as TRICARE, as well as privately funded health care benefit programs. Through IntegriMed and KA Compounding, Courtheyn recruited individuals to submit fraudulent claims for medically unnecessary compounded medications, such as pain creams, scar creams, wound creams, and metabolic vitamins, without regard to medical necessity. In total, Courtheyn defrauded health care benefit programs, including TRICARE, of at least $5.8 million.

Courtheyn faces a statutory maximum of five years in prison and a $250,000 fine, or twice the gross gain or loss from the offense, whichever is greatest. Sentencing is scheduled for July 20, 2022.

U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark; and the U.S. Department of Defense, Office of Inspector General, Defense Criminal Investigative Service, Northeast Field Office, under the direction of Special Agent in Charge Patrick J. Hegarty, with the ongoing investigation leading to today’s guilty plea.

The government is represented by Assistant U.S. Attorney Osmar J. Benvenuto, Deputy Chief of the Criminal Division in Newark.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
22-092
Updated March 14, 2022

 

FDA | Center for Drug Evaluation and Research 

TAINTED SUPPLEMENT


The Food and Drug Administration is advising consumers not to purchase or use Artri Ajo King, a product promoted and sold for joint pain and arthritis on various websites and possibly in some retail stores.

FDA laboratory analysis confirmed that Artri Ajo King contains diclofenac not listed on the product label. Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products. Consumers should immediately consult a health care professional if they are experiencing any side effects.

Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program. 


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